Several technologies are available to carry out leak detection in parental packaging. However, there are concerns with any detection mechanism as to how a package defect becomes a leak and mechanisms through which imposed pressures generated within a package during distribution and packaging of given products. There is also data available on the threshold of leak size to the critical leak size and its effects on the loss of package sterility. The threshold size is defined as a hole size at which onset of leakage occurs and threshold pressure is that which is required to develop a leak.
It is also known that fine particles at sub-micron scale can exhibit interesting optical properties and their optical characteristics can be tuned according to the environment they are exposed to.
The assurance of sterility maintenance is one of the prime concerns for procedures of aseptically packaged products. For the producers of aseptically packaged products, the low-cost, one hundred percent non-destructive, on-line inspection and evaluation of packaged products remains a top priority and somewhat unrealized. Any system or method which can reliably provide the information on the leak and integrity characteristics of packaged product is highly desired not only by pharmaceutical manufacturers by also by regulatory agencies like the FDA.
A leak in this context is defined as a breach in a package all, or a gap between package components which is capable of permitting the passage of a gas or liquid. Leaks in packaged products are rarely dimensionally uniform. They tend to be complex, multi-cavity tortuous paths. The integrity of a sterile product package keeps the product continents in their own containers.
As such, the key objectives in considering leak integrity testing are to keep the product contents in the container and to prevent environmental contaminants such as microorganisms, reactive gas and other substances from entering the container.
Usually leak rates as low as 2×10−2 mbar-liter/sec is considered to be significant enough to cause a loss of sterility or allow for micro-organism ingress.
The package integrity related recalls continue to cause problems for the pharmaceutical industry and multiple package types are impacted. For example, syringes, cartridges, vials, IV bags and ophthalmic solution bottles.
As such, there is a recognized need for a non-destructive leak testing and package development practice to guard against these shortcomings.